System and Method for Intracranial Access and Monitoring

ABSTRACT

A system and method for intracranial access is disclosed. In particular, a drill stop is shown providing a way to control the penetration of a drill bit as an access hole into the brain is being formed. Access to a desired location is achieved using a catheter guide device. Also disclosed is a mechanism by which multiple diagnostic and treatment devices can be placed at a desired location in brain tissue without the need for more than one access hole. A drainage catheter is disclosed with a mechanism to allow both drainage and to allow intracranial pressure measurement.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/970,360 filed Dec. 15, 2015, which is a continuation of U.S. patentapplication Ser. No. 12/792,650 filed Jun. 2, 2010, now issued as U.S.Pat. No. 9,232,921, which is a divisional of U.S. patent applicationSer. No. 10/855,159, filed May 26, 2004, now issued as U.S. Pat. No.7,780,679, which is related to and claims priority from U.S. provisionalapplication Ser. No. 60/475,056 filed on May 30, 2003, all of which arehereby incorporated herein by reference in their entireties.

BACKGROUND OF THE INVENTION

Systems and methods are disclosed which are directed to intracranialaccess for diagnostic as well as therapeutic indications, specifically,an access system, a ventricular catheter, a bolt insert assembly with aprobe guide and an introducer.

Access System: Drilling a Hole.

Twist drill devices presently used to drill a hole in the skull have twoshortcomings.

One shortcoming is an inability to stop drilling as soon as the drillbit has passed through the skull. A second shortcoming relates to theprocess of removing the bone material generated by drilling a hole. Thebone material must be carefully removed from the drill site around thedrill hole in a manner that minimizes the material that falls back inthe drill hole. It is important that the drill bit is stoppedimmediately after the drill bit passes through the skull. Anysignificant movement of the drill bit beyond the skull will traumatizethe brain. Currently, a hand drill is used to drill a hole in the skull.A drill stop is placed on the bit to act as a safety device. It preventsthe forward movement of the bit beyond a defined point and therebyprevents the drill bit from inadvertently plunging into the brain as aresult of continuing pressure on the drill after the hole is completed.The drill stop cannot be precisely located on the bit in a manner thatcauses the drill to stop forward motion as soon as it passes through theskull. The inability to precisely place the drill stop relates in partto the fact that the surgeon does not know the exact thickness of theskull. The drill stop allows the surgeons to partially drill through theskull without risk of plunging. When the hole is nearly complete, thedrill stop is loosened and backed off to allow additional forwardmovement so the bit can pass through the skull. The surgeon continues todrill very carefully until he senses that the tip of the drill bit haspassed through the bone. The sense of when the bit has passed throughthe skull is not precise and therefore, the distance the drill bit movesbeyond the bottom of the skull is not precise. Consequently, the drillbit may move more deeply into the brain than desired. The presentinvention provides a device that stops the drill bit as soon as it exitsthe skull and does so in a manner that requires no specialized skill onthe part of the doctor.

Access System: Removing Bone Material Generated by Drilling.

A second problem in current methods used to drill a hole in the skullrelates to the removal of the bone material that accumulates around thedrill bit. The bone material removed from the drill hole forms a sizableanthill-like pile adjacent to the hole. At the end of the drillingprocess, the doctor removes much of the bone material with a gauze clothand then removes the remaining material by rinsing the surrounding area.Some of the bone material is flushed into the drill hole in thisprocess. The present invention collects bone material as it is produced,thus preventing an accumulation of bone material around the drill hole.Removing the bone material as it is produced eliminates the need to swaband rinse the drill site.

Access System: Targeting a Ventricle.

Once the hole is created, the surgeon typically attempts to insert aventricular catheter through the hole and into a ventricle of the brain.The anatomy of the skull and brain is such that an imaginary lineperpendicular to the skull at the point of a drill hole will passthrough a ventricle. The surgeon aims the catheter at the ventricle byorienting the catheter as best he can so it enters the drill holeperpendicular to the skull. If the catheter is not properly orientated,the catheter will miss the ventricle and require that the surgeonwithdraw the catheter and try again. Several prior art devices have beendescribed that direct the angle of entry of the drill bit and or thecatheter. The devices are cumbersome enough that they have not beenwidely adopted. The present invention presents a device that directs theangle of entry of the catheter and does so in a simple-to-use manner.

Therapy: A Catheter with a Standard Drainage Capability.

One important aspect of any ventricular catheter is that of providing amultiplicity of radial holes that lead to a drainage lumen. Multipleholes reduce the likelihood that brain tissue or blood clots will blockthe flow of cerebral spinal fluid (CSF) into the drainage lumen. Priorart air-column ventricular catheters are constrained in the number ofradial holes that can be offered. Generically, an air-column catheterconsists of a flaccid bladder mounted to a catheter wherein an aircolumn extends from the bladder to an external transducer. The bladdervolume responds to changing ICP according to P₁V₁=P₂V₂. The bladder usedby the prior art air-column is an external sleeve, which is essentiallya tube with its ends bonded to the catheter body. The tube-shapedbladder covers the catheter body beneath it. The bladder length requiredby the system for proper operation is such that the bladder covers mostof the catheter body that resides in a ventricle. The room available forthe placement of radial drainage is therefore very limited. Thepredicate air-column catheter presents 4 radial holes vs. the 10 to 15radial holes provided in a standard ventricular catheter. An air-columncatheter with a sleeve bladder, therefore, has an inferior drainagecapability compared to a standard ventricular catheter now used.

In the present invention, the bladder is mounted within the catheter. Byplacing the bladder within the catheter, the entire surface of thecatheter body in the ventricle is available to provide radial holeaccess to the main drainage lumen and thereby provide the same drainagecapability as a standard catheter.

Therapy Access: Placement of Monitoring Probes and a Drainage CatheterThrough One Drill Hole.

In the course of managing patients, some neurosurgeons find it helpfulto measure parameters such as tissue oxygen. A three-parameter device ispresently available that provides access for ICP, O₂ and temperatureprobes. The device does not include the ability to drain CSF. RemovingCSF is an important therapeutic procedure in that it provides additionalvolume within the skull into which traumatized brain can expand. At thistime, a first hole is drilled into the skull for placement of thethree-parameter device. A second hole is then drilled in the skull toprovide access for a ventricular catheter. It is highly desirable toprovide a single-hole system that can provide access for multiplemonitoring probes such as ICP, oxygen and temperature and also provideaccess for a ventricular catheter. Such a system would avoid the need todrill a second hole.

Oxygen probes have a very specific placement requirement. They must beplaced in undisturbed tissue to obtain accurate values. In the priorart, the ICP, 02 and temperature sensors are placed straight down intothe brain through three parallel guide tubes. The oxygen probe isisolated from tissue disturbed by the other two probes by placing theoxygen probe deeper into the brain than the other sensors. Since aventricular catheter extends all the way through the brain to aventricle, a system that contemplates the placement of a ventricularcatheter and oxygen probe through the same drill hole must cause theoxygen probe to move laterally away from the track of the ventricularcatheter. As will be disclosed, the present invention provides anelement within a bolt that moves a probe laterally away from the trackof the ventricular catheter. Probes vary in their diameter and physicalproperties and may not interact well with an element designed to movethe probe to one side. The present invention uses an introducer withwell-defined pushability and memory characteristics to carry a probeinto the brain, thus ensuring that all probes can successfully be movedinto undisturbed brain tissue.

The introducer can be laterally displaced by placing a deflector at thedistal end of the guide tube. It can also be displaced by use of aprecurved introducer. Upon exiting a guide tube, the memory of theprecurved introducer causes the introducer to move away from the guidetube in an arc. A system that could place four functions, namely, O₂,temperature, ICP and a drainage catheter, through a single skull holewould address a clear clinical need by avoiding the need to drill asecond hole. The present invention allows all four functions to beplaced in the brain through one drill hole.

Adding a Third Parameter.

At this time, neurosurgeons are considering the use of other probes toproperly manage the patient. Flow probes, for example, are currentlybeing used to track changes in blood flow rates. In order to enable thedisclosed system to accept an additional probe without changing thediameter of the hole drilled in the skull, the oxygen probe is placed inan introducer that has an integrated temperature sensor. Temperature isa necessary input into the oxygen instrument since the oxygen value mustbe interpreted as a function of temperature. Combining oxygen andtemperature into an introducer frees one probe port for use by anotherparameter such as flow and does so without increasing the size of thebolt and its companion drill hole.

Objects and Advantages

One object of the invention is to stop the forward movement of a twistdrill bit as soon as it passes through the skull and to do so withoutrequiring skill on the part of the surgeon. The invention preciselystops the drill bit and does so without any expertise on the part of thesurgeon.

A second objective of the invention is to collect bone material removedfrom a drill hole as it is produced and thereby avoid an accumulation ofbone material that must be removed from the drill site by swabbing andrinsing.

A third objective of the invention is to provide a device that willguide the path of a ventricular catheter as it enters the brain.

A fourth objective of the invention is to provide an air-column catheterwith a sufficient number of radial holes leading to a drainage lumenthat they provide an inflow area typical of a standard catheter.

A fifth objective of the invention is to incorporate the ability to passmultiple monitoring probes plus a ventricular catheter through a singlebolt and thereby avoid the need to drill a separate hole for aventricular catheter. This objective requires that probes sensitive todisturbed tissue be moved away from the ventricular catheter track andinto undisturbed brain tissue.

A sixth objective is to accomplish the preceding objectives within theconfines of a diameter typical of the ventricular catheters now used.

A seventh objective of the invention to achieve a low cost product byreplacing some conventional design elements with design elements thatare less expensive to manufacture.

SUMMARY OF THE INVENTION

A cranial access system is disclosed that provides a precision drillstop, collects bone material removed from the skull, orients the axis ofthe drill hole so that it is perpendicular to the skull and provides acatheter guide that, when placed in the oriented drill hole, will guidethe path of a ventricular catheter toward a ventricle.

An air-column ventricular catheter is disclosed that has its bladdermounted inside the catheter body to thereby make the entire outersurface of the catheter available for the formation of radial drillholes. The drainage holes provide a drainage capability similar to thatof conventional ventricular drainage catheters and do so in a standardsize catheter.

A bolt and insert system is disclosed that makes possible theintroduction of four functions into the brain through one drill hole.Two of the functions, ICP sensing and CSF drainage, are incorporatedinto a catheter that is passed through a bolt. The bolt providesinsertion ports for two other parameters, such as oxygen andtemperature. Some parameters must be placed in undisturbed brain tissueto function properly. The system provides the ability to move such aprobe away from the track of the ventricular catheter and intoundisturbed tissue. The probes are placed in an introducer to provide aconsistent maneuverability characteristic to the various probes thatmight be used. One version of the introducer has a temperature sensorintegrated into the body of the introducer. It frees up one probe portand thereby makes it possible to introduce another parameter.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1a-h show a bone collection and drill stop system.

FIG. 2a shows a ventricular catheter guide.

FIG. 2b shows a ventricular catheter guide.

FIG. 2c shows a ventricular catheter guide.

FIGS. 3a-c show a bolt insert system that receives monitoring probes.

FIGS. 3c-d show the bolt insert system assembled on a ventricularcatheter.

FIG. 3e shows the placement of the assembly into a bolt that is screwedinto the skull

FIG. 4a shows the insertion of an introducer into the brain in a mannerthat moves an oxygen probe away from the track of a ventricularcatheter.

FIG. 4b shows the insertion of an introducer into the brain in a mannerthat moves an oxygen probe away from the track of a ventricularcatheter.

FIG. 4c shows the insertion of an introducer into the brain in a mannerthat moves an oxygen probe away from the track of a ventricularcatheter.

FIG. 4d shows the insertion of an introducer into the brain in a mannerthat moves an oxygen probe away from the track of a ventricularcatheter.

FIG. 4e shows the insertion of an introducer into the brain in a mannerthat moves an oxygen probe away from the track of a ventricularcatheter.

FIG. 5a shows a bladder within a perforated cage situated at the distalend of the catheter and shows a co-extensive placement of an air tubewithin the catheter wall.

FIG. 5b shows a cross section of the catheter and cage particularlyshowing the disposition of the bladder and the air tube.

FIG. 5c , which is section 5 c, shows a bladder in the cage in itscurved shape.

FIG. 5d , which is section 5 d, shows a D shaped bladder mountpositioned against the cage wall.

FIG. 5e , which is section 5 e, shows a U shaped channel in the catheterbody and the air tube that is placed therein.

FIG. 5f shows the air tube running inside the lumen of the catheter.

FIG. 5g shows an air tube in communication with a bladder mounted on theoutside of the catheter.

FIG. 5h shows the cross section of a typical two-lumen extrusion.

FIGS. 6a-e shows the incorporation of a temperature sensor into theintroducer, particularly showing the placement of the sensor wires onthe outside of the catheter.

DETAILED DESCRIPTION OF THE INVENTION

FIGS. 1a through 1h present a bone collection and drill stop assembly 1.FIG. 1a shows a partial cross section of the assembly. FIG. 1b shows thesame assembly rotated 90 degrees. FIG. 1c shows a plan view of a tripodassembly 1. FIG. 1d provides a section 1 d-1 d that shows a fork element9 in the tripod that is the upper stop of a spring 16. The spring causesthe bone collection device to stay in constant contact with the skull.

Precision Drill Stop.

A tripod 28 is placed on a scalp 8 that has been retracted to exposeskull bone 7. The tripod has a drill guide 21 through which a drill 27passes. The tripod drill guide causes the drill guide axis to be alignedperpendicular to an imaginary plane that is tangential to the skull atthe drill hole site. The anatomy of the head is such that the axis ofthe drill guide 21 passes through a ventricle. The forward motion of thedrill 27 is constrained by a drill stop 22, which is fixed to the drillbit 27 by a socket screw 23. The drill stop 22 allows the surgeon todrill into the skull bone without the risk of having the drill 27inadvertently passing through a completed hole and plunging into thebrain. The top surface of a drill stop 22 contact surface 24 is shown inFIG. 1c . It holds a pin 26. The surgeon senses when the drill bit tip27 first exits the skull as the torque required to rotate the drillincreases noticeably. At this time, the drill stop 22 is loosened andallowed to come down to rest on top of pin 26. The diameter of the pin26 is identical to the length of the conical tip of the drill bit. Thedrill stop 22 is then tightened and the pin 26 removed. The drill bit isnow free to move downward for a distance equal to the diameter of thepin at which time it contacts a drill stop contact surface 24. Since thediameter of the pin 26 is the same as the length of the tip of the drillbit 27, he distance that the drill bit 27 will pass through the skullwill be substantially equal to the diameter of the pin 26 (and thussubstantially equal to the length of the tip of the drill bit 27 when itcontacts the drill stop contact surface 24).

A second approach to controlling the forward motion of the drill bitallows the surgeon to sense when the bit has passed through the skull inaddition to sensing when torque increase as the bit breaks through theskull. The second approach reduces the risk that sensing a change intorque may not always be reliable. It may be difficult to sense torqueif the available electric drill lacks speed control or if the patient'sskull might be expected to be abnormal. The single pin 26 is replaced bya number of removable clips such as a C clip 90. As seen in FIG. 1e ,the drill guide 21 has a thin cylinder rising above it to form a sleeve29. As seen in FIG. 1f and 1g , the C clips can be snapped around thesleeve. Each sleeve is in essence a contact surface in addition tocontact surface 24. The C clips are about 1 mm in thickness. If thesurgeon's best estimation as to where to set the drill stop is three mmabove the actual bottom of the skull, the drill bit can be allowed toadvance in a step wise fashion until the drill passes through the skull,The distal end of the drill stop has an enlarged cylinder 92 andenlarged feet 94 to be compatible with the C clip design. A secondapproach is to have a threaded section on the distal end of the drillstop. Surgeon turns threaded part. 1 turn=1 mm advance.

Bone Collection.

With continuing reference to FIGS. 1a and 1b , a collection container 11is positioned below the tripod top surface. It has an auger tube 10 atits distal end. The diameter of the tube 10 is about 0.005 of an inchlarger than the 0.25-inch drill bit. 27. The clearance between the augertube 10 and the drill bit 27 is sufficient to cause the drill bit flutesand tube 10 to act as an auger. The auger tube 10 lifts a bone material14 produced during the drilling process up and into the collectioncontainer. 11. The collection process eliminates the need to remove bonematerial from around the hole that might fall into the drill hole. Ayoke 9, shown in FIG. 1b , is an integral element of the tripod. Aspring 16, residing between the yoke and the collection container, keepsthe tip of the auger tube in contact with the skull as the drilladvances into the skull. As shown in FIG. 1d , the collection tube has acontainer guide slot 18 that slides in a tripod guide bar 20. It keepsthe collection container attached and aligned with the tripod.

Catheter Guide.

FIGS. 2a and 2b show a catheter guide 34. The scalp is retracted and ahole is drilled through the bone using the tripod previously described.The anatomy of the head is such that the axis of the drill guide and theaxis of the drill hole intersect a ventricle 31. The catheter guide isinserted into the drill hole and held in place by the interferencebetween the bone hole and the body of the guide. A flange 37 on thecatheter guide is seated against the skull. The flange stops themovement of the guide into the hole and also tends to square the axis ofthe guide 34 with the axis of the drilled hole. A ventricular catheter40 inserted into the guide 34 will be aimed directly at the targetventricle 31. After the catheter is in place within the ventricle 31,the guide is removed from the hole. The catheter is then removed fromthe guide through an exit slot 36.

Insert Assembly.

FIGS. 3a-c show an insert assembly 2. The basic element of the assemblyis an insert body 60 with an insert a-ring 59 and a bolt clamp 66. Asshown in FIG. 3c , a catheter pigtail 63 is adhesively attached within acatheter port 62 of the insert body. The proximal end of the pigtail 63is terminated by a Toughy-Borst fitting 65. A probe pigtail 64 isadhesively attached within a probe port 61 of the insert body. Theproximal end of the pigtail is terminated by a luer fitting 75. A guidetube 68 is bonded into the bottom of the probe port. As will bedescribed later, a guide tube 68 is used to direct a monitoring probeinto the brain.

Catheter Assembly.

A catheter assembly 3 consists of the insert assembly 21 plus a cathetersubassembly 4, which is shown in FIG. 5a . The catheter subassembly 4will be described later. As shown in FIG. 3c , the insert assembly 2 isassembled with a ventricular catheter 40 at the factory. The surgeonplaces the combined catheter 40 and insert assembly 21 into a ventriclewith the assistance of a stylet 57. The surgeon then moves the insertassembly 2 down the catheter and into a bore 82 of a bolt 80, shown inFIG. 3d . The insert a-ring forms a seal between the insert 2 and bore82. The bolt clamp 66 engages a capture lip 84 and fixes the insertassembly 2 to the bolt 80. The final configuration of the catheter 40,the insert assembly 2 and the bolt 80, is shown in FIG. 3 e.

Probe Insertion.

A principal function of the invention is to facilitate the placement ofmonitoring probes into the brain. As shown in FIGS. 4a and 4b , theprobe pigtail 64 and guide tube 68 provide an access path to a brain120. An introducer 130 carrying a probe 86, shown in FIG. 4a , isinserted through this access path. The introducer, the probe and itssensor will be described later.

Some probes are sensitive to the nature of the tissue in which they areplaced. In order to get an accurate reading, the distal tip of suchprobes must be placed in tissue that has not been disturbed by thenearby passage of a catheter. A ventricular catheter 40 shown in FIG. 3c, when placed down the bolt 80, disturbs the tissue near the tractthrough which it passes. A sensitive probe must therefore be directedoff to one side. FIGS. 4a and 4b describe the elements involved in twodesigns that direct the introducer carrying a probe away from the axisof the bolt down which a ventricular catheter has been placed.

In the first design, the introducer 130 is directed away from theventricular catheter 40 by an elbow 72 shown in FIG. 4d . The elbow 72is formed in the distal end of the guide tube 68. The displacement ofthe introducer 130 from the track of the ventricular catheter 40 isindicated by dimension A.

FIG. 4b shows a second scheme, which involves the use of a precurvedintroducer 131. In this design, the introducer 131 is precurved to adefined radius. The introducer 131 is passed down the guide tube 68. Theguide tube 68 straightens the introducer 131 until it exits the distalend of the guide tube 68. At that point, the memory of the introducercurve causes the introducer 131 to follow an arced path that moves itaway from the track of the ventricular catheter 40. The displacementdistance is again represented by A. The precurved design requires afeature that prevents the possibility of the curved introducer 131rotating in brain tissue. As shown in FIG. 4c section 4 c-4 c, theintroducer 131 and pigtail 64 in one design have a D cross section. Theshape of the two parts prevents the introducer 131 from rotating withinthe pigtail 64.

A second approach to preventing rotation of the introducer in braintissue is shown in FIG. 4e . In this approach, the cross section of boththe introducer 130 and pigtail 64 are circular. A collar-with-a-pin 160is bonded to the probe pigtail 64. Once the insert 2 has been placed inthe bolt 80, the pin 160 is snapped into a socket 162 molded into thebolt 80. The pin-in-socket fixes the probe pigtail 64 and preventsrotation about its vertical axis or twisting about its horizontal axis.

Catheter Subassembly.

As shown in FIGS. 5a and 5b , a catheter sub assembly 4 consists of acatheter body 39, a bladder cage 44 with radial holes 46 that perforatethe cage wall in rows and columns. As shown in FIG. 5b , a bladder 49,section 5 c-5 c, FIG. 5c , is placed on a bladder mount 48, section 5d-5 d, FIG. 5d . An air tube 50, section 5 e-5 e, FIG. 5e , is insertedinto the bladder mount 48. It is placed in a U channel 77 moulded intothe wall of the catheter body 39. The air tube extends along the lengthof the catheter until it exits near its proximal end. The air tube 50 isconnected to a more robust air tube extension 52 in a bifurcation 56 tomake a kink resistant design. The catheter diameter is reduced by usinga separate tube as the air column rather than using a second lumen of acatheter extrusion. The air tube 50 has a thin 0.0015 inch wall, whichserves to minimize the catheter OD. As shown in FIG. 5f , the air tube50 could also be positioned within the catheter lumen 47 of a catheterbody 39. The placement of the air tube in a U channel or within a lumencan be applied to a catheter with either an internal or externalbladder. FIG. 5g shows a catheter with a bladder 20 mounted on theexterior surface and an air tube running within the lumen. The air tube50 passes through a hole 58 in the catheter wall located within theconfines of the bladder 20. FIG. 5h shows the cross section of aconventional two lumen extrusion. It consists of a catheter body 39, alarge lumen 47 and a small lumen 59. A comparison the extrusion of FIG.5h with the single lumen catheter of FIG. 5f or the dual lumen catheterof 5 h shows the larger area of plastic material required to form a duallumen extrusion. The more material-efficient construction of the singlelumen catheter and tube makes it possible to reduce the diameter of thecatheter used in the ICP application from a 8.5 Fr to a 7.5 Fr.catheter. The catheter with the U channel shown in FIG. 5e is slightlymore efficient than the air tube within the lumen construction shown inFIG. 5 f.

As will be discussed, the placement of the bladder 49 in a cage 44accomplishes three of the inventions objectives. It minimizes thediameter of the catheter body 39, makes possible the placement of abladder 49 within a catheter that is small in diameter and provides adrainage capability similar to that of standard ventricular catheters.The cage 44 is bonded to the end of the catheter body 39. The bladder 49is placed on a bladder mount 48. The mount 48 is D shaped to move it tothe side of the drainage lumen and to thereby provide a drainage channelthat, at its minimum dimension, is similar to the passage way providedin a standard catheter. The minimum dimension is important in that itdefines the size of blood clots that can pass through the drainagelumen.

The catheter body 39 is made of polyurethane. The bladder cage 44 ismade of a thin wall polyimide tube. The use of polyimide provides a 7.5Fr. catheter with a larger ID than would be the case if the cage segmentwere polyurethane. The larger ID makes it possible to house the bladder49 within the catheter and achieve a minimum flow path dimension, allwithin a catheter diameter similar to the standard drainage-onlyventricular catheters now used. The wall thickness of the polyurethanecatheter is 0.10 inch. The wall thickness of the polyimide cage is 0.002inch. The use of polyimide increases the ID of the segment of thecatheter in which a bladder mount 48 and a bladder 49 are located. Thedifference in the thickness between the polyimide and urethane wallsamounts to 0.016 inches (0.02-0.004), which is equal to 1.2 Fr. Thecatheter body is 7.5 Fr. An all-polyurethane catheter would have to bealmost 9 Fr. to provide the same internal diameter as the polyimidecage. The use of a polyimide gage is thereby an important element inachieving the objective of minimizing the diameter of the catheter.

Drainage Capability.

The polyimide tube also increases the drainage capability of thecatheter. As shown in FIGS. 5a and 5b , radial holes 46 pass through thecage 44 wall and allow cerebral spinal fluid (CSF) to enter a drainagelumen 47. The thin wall and the strength of polyimide make it possibleto drill closer spaced radial holes than would be the case with apolyurethane catheter. The increase in hole count thereby provides alarger total cross section of radial holes leading to the centraldrainage lumen of the catheter. Four rows with 8 holes per row aredrilled into the cage for a total of 32 holes. Each hole is 0.9 mm indiameter. A standard ventricular catheter typically has 10-15 1 mmholes. A prior art air-column catheter has 4 radial holes. The closespacing allowed by the use of a thin wall rigid polyimide tube makes itpossible to present a larger radial hole flow path than is practical inthe thicker wall of a flexible polyurethane or silicone catheter. Thepolyimide cage 44 with the hole count as presented herein has 2 timesthe total radial hole diameter of a standard catheter and 8 times theradial hole area of a prior art air-column catheter.

Small Diameter Catheter.

A bladder 49 functions within the polyimide cage 44. When collapsed byICP, the bladder 49 goes from its normal cylindrical shape to a flatshape. A bladder 49, when flattened, is 1.5 times as wide as thediameter of the cylinder prior to flattening. In order to use a small ODcage, the bladder 49 is caused to assume a C shape. A 0.070 diameterbladder 49 is used in the design. The bladder's flattened width is 0.110inch. The bladder 49 is placed in a cage 44 with an ID of 0.098 of aninch. When collapsed by ICP, the bladder 49 assumes a C shape with aradius of slightly over 0.2 inch. In order to function while in a Cshape, the bladder material, bladder wall thickness, bladder volume andvolume of injected air must be closely controlled. A relative thick wallor excess of injected air will prevent proper operation of a C shapedbladder. An example of a bladder with the requisite characteristics is a0.55-inch long bladder 0.070 inches in diameter having a 0.003 thickwall made of butyl rubber. The volume of air injected is limited to 10μl.

The shape and location of the mount 48 upon which the bladder 49 isplaced is an important element in integrating the various functions ofthe catheter into a small diameter catheter. As shown in FIG. 5b ,section 5 d-5 d, a bladder mount 48 has a reversed D shape and ispositioned against the side of the polyimide tube 44. The mount shapeand placement allow the most narrow drainage passageway in the innerlumen to be similar to the diameter of the drainage lumen of a standardventricular catheter. The ID of the polyimide tube is 0.098 inches. Thewidth of the D is about 0.045 of an inch. The thickness of bladder wallis 0.003. The width of the bladder and mount is 0.051 of an inch. Theclearance between the mount and the 0.098 ID cage wall is thereforeabout 0.047 of an inch. If a conventional cylindrical shaped bladdermount were used and placed against the side of the cage, the minimumclearance would be decreased from 0.047 of an inch to 0.025. A catheterwith a center positioned bladder would have to be 2 Fr. larger indiameter than the present design to provide a minimum clearance of about0.050 of an inch. The use of a D shaped bladder mount and a bladder thatcan operate in a C shape are important design elements in achieving asmall diameter catheter that offers a standard drainage capability.

A fourth design element also contributes to achieving a small diametercatheter. Heretofore, a second lumen has been used as the air columnbetween the bladder and a transducer. In the present invention, aseparate tube is used as the air column. As seen in comparing thetypical cross section of the two lumen extrusion in FIG. 5h with aseparate tube construction of either FIG. 5e or FIG. 5f , a separatetube substantially reduces the amount of plastic material used. In thecase of the ICP catheter, the separate tube design requires the use of ⅓less material than the two lumen extrusion. The reduction in materialusage can be used to effect a proportional reduction in catheterdiameter or can be used to increase the diameter of the non-air columnlumens. A smaller diameter catheter has merit in an ICP application andis of value in any catheter introduced into the body. It is ofparticular merit when catheter diameter affects its intended functionsuch as in a uro-dynamic catheter that measures the constrictive profileof the urethera. In the urodynamic application, the more optimal use ofspace can be used to reduce the catheter diameter or increase thediameter of the filling lumen. In the ICP catheter application, the airtube 50 is isolated from a drainage lumen 47 by placing it in a channel77 formed in the exterior of the catheter. The external placement keepsthe air tube from being randomly disposed with the drainage lumen whereit might interfere with the passage of material entering the drainagelumen. As shown in FIGS. 5a and 5b , an air tube 50 extends from thebladder mount 48 to the proximal end of the catheter. As shown in FIG.5e section 5 e-5 e, the catheter body extrusion 39 has a U channel 77 inthe sidewall. The wall of the catheter can be quite thin at this pointsince the air tube 50, when potted into the U channel 77, more thanmatches the strength of the normal wall thickness. The air tube 50 exitsthe cage directly below the U channel 77 in the catheter wall and isplaced in the U 77, where it runs up the side of the catheter

As seen in FIG. 5a-b , the air tube 50 coextends along the length of thecatheter to about 1 inch from the catheter's proximal end. At that pointit enters an air tube bifurcation 56 where the catheter and air tube 50are separated. The air tube 50 is joined to an air tube extension 52within the bifurcation 56. The air tube extension 52 has sufficient wallthickness to resist kinking forces that may be encountered proximal tothe bifurcation 56. The air tube extension 52 connects to a piston,which, in combination with a transducer housing, injects the requisiteamount of air to enable the bladder to operate as described in U.S. Pat.No. 5,573,007, the entire contents of which is hereby incorporated byreference.

In summary, the insert assembly consists of an insert body that holds acatheter pigtail, two probe pigtails, two guide tubes, a sealing a-ringand a bolt clamp that secures the insert to the bolt when the clampengages the capture lip of the bolt. The catheter assembly consists of acatheter body, a thin wall cage that holds the bladder on a D-shapedbladder mount and provides a large number of radial holes that feed thedrainage lumen. The air tube is held in a channel that runs along theoutside of the catheter.

Probe Placement.

The sensor of some monitoring probes is placed in a soft, highlyflexible tube. Such a probe may be unable to be redirected intoundisturbed tissue as it can neither interact with a deflector nor canit be precurved. The present invention provides the properties necessaryto locate such a probe in undisturbed tissue by inserting it into anintroducer. The introducer can be made stiff enough to be directed by adeflector or can be imbued with a memory to produce a precurvedintroducer. As shown in FIG. 6a an assembly 5 consists of a probe, anintroducer and the pigtail to which the introducer is attached. A probe86 has a luer connector 78. The probe is inserted into an introducer130. The introducer has a luer fitting 77 on the proximal end as well asa luer fitting 76 located about 1 inch from the proximal end. The probe86 is inserted into the introducer 130 until its luer 78 encounters theproximal luer 77 of the introducer. The luers are mated. The introducer130 is then inserted into the probe pigtail 64 and advanced until a luer76 of the introducer 130 can be joined to a luer 75 of the pigtail 64.The probe 86 can be placed in the brain at any depth desired by varyingthe location of luer 76 and the length of the probe pigtail 64.

The introducer is filled with water before the probe is inserted. Thewater displaces air that would otherwise be present in the annulusbetween the probe and introducer ID. The removal of air assures that theoxygen sensed by the probe will be that of the brain and not that ofentrapped air.

Introducer with a Temperature Sensor.

The two most used probes at this time are oxygen and temperature.Temperature is required to interpret the oxygen signal and is thereforevery commonly used. At times, there is a need to place more than twoprobes into the brain such as a flow probe or a dialysis probe. Onesolution to the access problem, of course, would be to provideadditional probe ports by using a larger bolt, which would then requirea larger diameter hole in the skull. Rather than increase the boltdiameter, the present invention frees up a port by incorporating atemperature sensor 155 into the introducer 130 as shown in FIG. 6b . Theguide tubes 68 are designed to accept an introducer 130 with a diameterof about 0.050 of an inch. An introducer lumen 154 receives a probe 86that is about 0.030 of an inch in diameter. The available wallcross-section area is therefore very limited. The thermocouple wire usedfor temperature measurement must be of a small diameter of about0.003-0.005 of an inch. Referring to FIG. 6b , a sensor wire set 152 isplaced in a U channel 89 that extends the length of the catheter to abifurcation 154 shown in FIG. 6e . The wire set 152 is joined to a largediameter wire 156 within the bifurcation. The larger diameter wire 156is sufficiently rugged to extend from the catheter to an instrument. Thesensor 155 and wires 152 are placed in the channel 89 and potted inplace with UV adhesive. The concept of running a second function up achannel in the side of the catheter rather than through a second lumenwas discussed earlier. In the case of the introducer 130, an approachwherein a second lumen is used to string the wire from the proximal todistal end would make assembly difficult. The second lumen diameterwould be less than 0.010-inch diameter. Piercing such a hole in the wallof such a small lumen and stringing wire through it and down a lumenpresents a difficult fabrication problem. The concept of running a wireup an exterior channel is valuable in that it both minimizes thecatheter OD and reduces the cost of fabrication.

In the case where a sensor may be too large to fit in the narrow channel89, the sensor can be positioned within the lower portion of the sidewindow 159 as shown in FIG. 6d . In this arrangement, the channel needonly accommodate the sensor wire or fiber optic. The potting materialused to secure the sensor in the window has been omitted from thedrawing for sake of clarity. If the sensor is a light based sensor, suchas one using an LED, the potting material must be transparent. If it isnot an optical sensor, the sensor can be potted in place with anybiocompatible adhesive. Since the parameters measured by sensors changeslowly within the brain, the reduction in response time due tosequestering the oxygen probe or temperature probe within the introducerwill not affect the utility of the sensor.

Operation of the Invention

Bone Collection.

The hole drilled in the skull to gain access to the brain produces aquantity of bone material that piles up around the drill hole like ananthill. The skull may be 0.25-75 inches deep, therefore the amount ofbone material created can be substantial. In the prior art, the bonematerial is removed by a combination of swabbing and flushing. Some ofthe bone material falls back into the hole in the cleaning process.Removing the bone material takes time and contaminates the operationsite. The present invention creates a bone collection system by creatingan auger that consists of the flutes of the drill bit and a surroundingtube.

The bone material is carried up the auger and deposited in a collectioncontainer. It is important that the tube stay on the skull so the bonematerial cannot escape through a gap between the tube and skull. Thebone container is therefore spring loaded against the tripod to which itis mounted. The surgeon normally uses a hand drill to drill a hole. Bothhands are occupied in this process. In the present invention, anelectric drill is used, which only requires the use of one hand thusfreeing the second hand to hold the tripod in place.

Precise Drill Stop.

A skull hole is usually drilled with a hand-operated drill. Thelimitations of present drill stops are such that a simple electric drillis not used. If the drill bit is driven by an electric drill, themomentum of the motor can be such that the spiral flutes will pull thedrill down into the brain once the body of the bit exits the skull. Theavailability of an improved drill stop that would make it possible foran electrical drill to be used would be an important improvement. Itwould remove the risk that the bit might be pulled into the brain,reduce the time required to drill the hole and free a hand to makepossible the use of tripod described earlier. At present, the surgeonsets the drill stop so it will stop the bit short of the estimatedthickness of the skull. The setting is imprecise since the surgeon doesnot know the exact thickness of the skull. When the drill stopencounters the skull, the drill stop is untightened. The surgeon thenproceeds cautiously until it seems that the drill bit has passed throughthe skull. It is difficult to sense when the drill is just about throughthe last segment of the skull. It is therefore likely that the bit willeither stop short of full penetration or will pass below the skull somedistance. A premature stop will leave a bone edge sticking out that maydamage sensors inserted through the hole. Passage of the drill bit intothe dura will push will either tear it or push it away from the skulland cause bleeding.

The present invention enhances the traditional drill stop by adding aprecision stop feature. It differs from a standard drill stop in severalways. A normal drill stop stops when it contacts the skull. There is noroom for a second element to provide a more precise stop. In the presentinvention, the drill stop operates above the skull. By controlling thestop above the skull, it is possible to add an element that preciselycontrols the depth of the drill. The torque required to turn the drillincreases when the tip of the drill bit passes through the skull. Thesurgeon, sensing the high torque event, stops drilling at this point,moves the drill stop down to the pin and tightens it. He then pulls thepin on the top of the drill guide at which point he can resume drillingwith the assurance that the drill bit will stop as soon as it hastraveled a length equivalent to the diameter of the pin, which is adistance equal to the length of a drill bit tip. A more conservativeprecision drill stop can be made by placing a number of C clips 90 on asmaller diameter segment 29 of the tube guide 21 (See FIG. 1f ). Thedrill stop ID 92 is increased to allow ingress of the smaller diametersegment. A flange 94 is placed on the distal end of the drill stop. Itstops the drill stop when it reaches a contact surface. The drill stopdesigns discussed allow the forward motion of the drill bit to proceedin small well controlled steps. Several other methods of preciselycontrolling the forward motion of the drill bit can be envisioned suchas a threaded distal end of a drill stop that has a nut wherein theposition of the nut defines the allowable forward motion of the drillstop.

The system has several advantages other than precisely stopping the bitafter the body passes through the skull. An electric drill is fairlystable and is not subject to the wobble introduced by a hand turned bit.The wobble tends to produce a conical hole until the bit has entered thebone to some extent. The conical shaped hole reduces the effectivelength of the threaded section of the bolt, which makes for a lesswell-anchored bolt. The use of an electric drill also frees one hand tohold the tripod in place.

In order to assure proper control of the drill, a driver is chosen thathas a rotational speed of about 200 rpm, is light in weight and islimited in its torque capability so it grabs and stops when it hits thehigh torque event associated with the point of the drill passing throughthe skull. The appropriate weight and torque capability will vary withthe diameter of the hole, but the appropriate combination can easily bedetermined empirically for any given drill diameter.

Catheter Guide.

Head trauma treatment frequently involves placing a ventricular catheterinto a ventricle within the brain to provide a means of removingcerebral spinal fluid (CSF) and thereby increase the volume within theskull into which swollen brain tissue can move. The placement procedureinvolves aiming a catheter down an oversized drill hole and moving ittoward the brain at an angle that will hopefully intercept the targetedventricle. The patient is usually lying on a bed tilted to a 30-degreeangle. The head is an irregular shaped object. Given the head's angle,the lack of simple guidance landmarks and the fact that the procedure isinfrequently done by most neurosurgeons, the placement procedure isdifficult. It is not uncommon to miss the ventricle and to thereforehave to try again. The present invention assists in placement by closelycontrolling the angle of entry of a ventricular catheter. It does so byfirst drilling a hole with an axis that intercepts the target ventricle.The orientation of the hole is accomplished by using a tripod 28 withits drill guide 21.

The tripod provides the ability to orient the axis of a drill hole. Itis well understood that an imaginary line perpendicular to the surfaceof the head will intercept a ventricle in the brain. The planer surfacejoining the legs of a tripod is parallel to the skull. The axis of theguide tube 21, which is perpendicular to the planer surface, thereforeintercepts a targeted ventricle. The guide tube orients the drill bitand causes it to drill a hole whose axis passes through a ventricle. Acatheter guide 34 is placed in the oriented hole and its flange seatedagainst the skull. The guide presents a long small diameter aperturethat closely defines the angle at which the ventricular catheter entersthe brain. The use of an aligned catheter guide with an elongated smallaperture greatly increases the likelihood of successful placement.

Therapy: A Catheter with a Standard Drainage Capability.

A principal function of a ventricular catheter is that of draining CSF.It is not uncommon for the drainage function of the catheter to bedisabled by blood clots or brain tissue that clog the radial holesleading to the central drainage lumen.

The design of prior art air-column ventricular catheters is such thattheir drainage capability is compromised. The bladder used is a sleevebladder. The tubular sleeve is slipped on the catheter, and then bothends of the sleeve are joined to the catheter body. The length of thebladder required in the prior art system is such that most of the lengthof the catheter that might reside in a ventricle is covered by thebladder. Consequently, the distal end of the catheter has but 4 radialholes that lead to the drainage lumen. A standard ventricular catheter,in comparison, has 10-16 holes.

The present invention uses a small bladder that can be placed inside thecatheter. The entire body of the catheter is therefore available for theplacement of radial holes near the distal end. The design has a secondelement that further increases the drainage capability of the catheter.Standard catheters are made of silicone or urethane that have a thickwall so the tube will not kink when subjected to bending forces whenoutside the skull. The body of the catheter of the present invention isalso urethane for most of its length. The distal end wherein the radialholes are placed is made of polyimide, a somewhat rigid material. Thematerial properties are such that holes can be more closely drilled thanis the case with polyurethane. The present invention capitalizes on thematerial properties by providing, in a preferred embodiment, 32 laserdrilled radial holes. The drainage capability is therefore about 8 timesthat of the prior art air-column catheter. The likelihood that materialmay become logged in a radial hole is also reduced in that the length ofthe radial hole is reduced from 0.01-0.02 inches to 0.002 inches. Theshorter hole of the polyimide tube is less likely to become plugged byincoming material than the longer hole of a standard catheter.

Standard Catheter Diameter.

Standard ventricular catheters are about 7 Fr. in diameter. Catheterswith a built-in pressure sensor are 9-10 Fr. in diameter. Obviously, asmaller diameter catheter is to be preferred to a larger diametercatheter. An objective of the present invention is to provide amulti-sensor catheter that is approximately the same size as thestandard drainage-only catheters. One of the principal requirements ofany drainage catheter is that the main drainage lumen be larger than theradial holes that feed it. The larger diameter drainage lumen makes itlikely that anything passing through the radial holes will pass throughthe main drainage lumen. A standard ventricular catheter has an ID of0.052 inches. One objective of the present invention is to produce acatheter that has a minimum passageway of about 0.050. The bladder usedis 0.070 inches in diameter, which is about as small a diameter as itpractical to make and assemble. The bladder must be mounted on a bladdermount. A combination of three design concepts makes it possible for thedrainage lumen to have a minimum passageway of about 0.050. The firstconcept is that of placing the bladder in a polyimide cage rather thanin the body of the urethane catheter. Because of its strength, the wallof the polyimide cage can be quite thin, in this case, 0.002. Apolyurethane catheter wall, in contrast, needs to be 0.010. The twowalls of the polyimide tube total 0.004 inches vs. 0.020 inches in thecase of a polyurethane catheter. Placing the bladder in a polyimide cagerather than a polyurethane tube reduces the diameter of the catheter by1.2 Fr. sizes.

A second concept that affects the diameter of the catheter is the shapeof the bladder mount. Rather than mount the cylindrical bladder on acylindrical mount, the bladder is mounted on a D shaped mount. The mountand its bladder are moved against the inner wall of the cage to therebypresent the maximum clearance between the cage wall and the bladdermount. As described earlier, a D shaped mount placed at the side of thecatheter allows the bladder to function in a catheter 2 Fr. sizessmaller than would be the case if a cylindrical mount were used. Thethird concept that affects overall catheter diameter is that ofisolating the air tube from the drainage lumen. The air tube must beprevented from running through the drainage lumen, as a random placementwill reduce the minimum passageway dimension. The conventional approachused to isolate a second function, such as the air tube, is to provide acatheter with a second lumen. The present design minimizes the diameterof the air tube by placing a thin wall polyimide tube within a U shapedchannel formed in the outer wall of the catheter. The U channel runs upthe side of the catheter. The thin wall air tube has a 0.0015 inch thickwall. If housed in a supporting U shaped channel, the physicalproperties of the thin wall polyimide are adequate. The wall thicknessof an air tube made of conventional materials such as polyurethane ornylon tube would be about 0.01 inches thick. A catheter usingconventional materials would therefore be larger in diameter.

External placement of the polyimide tube eliminates the need for asecond lumen and thereby eliminates the thickness of the septum wallrequired to form a second lumen. The thin wall polyimide tube isincapable of withstanding kinking forces encountered once it exits thecatheter. The tube is therefore joined to a more robust tube in abifurcation fitting located at the proximal end of the catheter.

The external placement of the air tube provides another benefit. Iteliminates the need to perforate the catheter wall to gain access to asecond lumen. The cost of potting the air tube in the catheter channelis somewhat less expensive than the process involved in perforating thecatheter wall and inserting the tube within the second lumen. Thereduction in cost provided by running a second catheter function in achannel in the side of the catheter increases as the diameter of thesecond lumen that would otherwise be required decreases. The costbenefit is particularly important in small catheters as will bediscussed later when describing an introducer with a temperature sensor.

Introduction of Several Monitoring Probes.

The care of certain patients who have undergone brain trauma has changedin the recent past. Until recently, the only devices placed in the brainwere an intracranial pressure sensor (ICP) or a combination ICP sensorand drainage catheter. Recently, surgeons have desired the placement ofan oxygen sensor and a temperature sensor. A temperature sensor isrequired, as the oxygen signal must be interpreted as a function oftemperature. Other probes are being placed in experimental work and maywell become a standard of care. The probes include blood flow anddialysis devices.

The only prior art device now available for measuring oxygen has a boltand guide tube system that have the ability to accept an ICP sensor, anoxygen sensor and temperature sensor. It cannot, however, pass adrainage catheter. A drainage capability is provided by drilling asecond hole in the patient's head and placing a catheter in a ventriclethrough the hole. The matter of adding a ventricular catheter to athree-parameter system must deal with the fact that an oxygen probe mustbe placed in undisturbed tissue to provide a correct reading. The priorart device, which consists of three parallel guide tubes aligned withthe axis of the bolt, isolates the oxygen probe by placing it down itsguide tube to a deeper level than the temperature and ICP sensors. Thisstrategy cannot be used if a ventricular catheter is to be passed downthe bolt as the catheter extends from the skull to a ventricle. Thetrack of the catheter nearly parallels the axis of the bolt. An oxygenprobe placed straight into the brain would encounter disturbed tissue.The present invention provides a capability to insert an ICP sensor, anoxygen sensor, a temperature sensor and a drainage catheter through onehole and to do so in a manner that locates the oxygen probe inundisturbed tissue. The system consists of a bolt that is screwed into askull hole and a catheter that can measure ICP and drain CSF. A plasticpart, an insert assembly 2, has two pigtails through which probes may beinserted and two guide tubes that guide probes into the brain. Theinsert is placed on the catheter at the factory. As soon as theventricular catheter is inserted into the brain, the insert is moveddown the catheter and placed in the bore of a bolt that has been screwedinto the skull hole.

The oxygen probe is moved away from the track of the catheter intoundisturbed tissue as it is introduced into the brain. The presentinvention describes two designs that move the probe away from thecatheter track. Either design can be used with an introducer 130 or 131.The introducer provides a consistent pushability characteristic toprobes that may be used. In one design, a guide tube 68 has an elbow atits distal end. The elbow causes the introducer to exit the guide tubeat an angle roughly of 30 to 45 degrees. In a second design, theintroducer is precurved. After it passes through the guide tube, thememory of the introducer causes the introducer to follow a curved trackthrough the brain. The introducer of the precurved design can beprevented from rotating about the bolt axis by either one of twoapproaches. In one approach, the pigtail and introducer are D shapes orelliptical so the introducer cannot rotate within the pigtail. In asecond design, a pin-with-a-collar 160 is bonded to the probe pigtail.The collar has a pin that can be snapped into a socket 162 molded intothe wing of the bolt. The collar prevents the pigtail from moving.

The depth to which the probe is inserted can be controlled by varyingthe length of the probe pigtail, the length of the introducer and thelocation of the mid luer on the introducer. The system can thereby betailored to be used with any probe.

Introducer with a Temperature Sensor.

Although oxygen and temperature are the most commonly used probes, bloodflow sensors and dialysis probes are being placed in some patients. Thebolt and insert of the present invention are designed to receive twoprobes. Although a third probe port could be added by increasing thediameter of the bolt and adding a third probe port to the insert, apreferred approach is to place the oxygen and temperature sensor in oneintroducer and thereby make a second probe port available withoutincreasing the size of the drill hole. In order to fit a temperaturesensor within the limited cross sectional area of the introducer and asa means of keeping the cost of manufacture down, the temperature sensorand its wires are placed in a U shaped channel that runs the length ofthe catheter. The oxygen sensor is placed in the main lumen. The sensorand wires or fibers of the temperature sensor run within the channel.The sensor is bonded at the distal end of the introducer within thechannel if it is small enough in size to fit. If it is too large, thesensor is placed within the window 159 in the distal tip of theintroducer as shown in FIG. 4 d.

It is understood that the preceding description is given merely by wayof illustration and not in limitation of the invention and that variousmodifications may be made thereto without departing from the spirit ofthe invention as claimed.

The invention claimed is:
 1. An intracranial access device, comprising:a bolt mountable in a skull of a patient, the bolt having a longitudinalaxis; an insert body having a plurality of access ports extendingthrough the bolt, the insert body being attachable to the bolt; and acatheter assembly positioned within one of the access ports of theinsert body.
 2. The intracranial access device of claim 1, wherein thecatheter assembly comprises a catheter body and a bladder incommunication with the catheter body.
 3. The intracranial access deviceof claim 2, wherein the bladder is positioned within a bladder cageformed external to the bladder.
 4. The intracranial access device ofclaim 2, wherein the bladder is positioned along the catheter body. 5.The intracranial access device of claim 1, wherein the catheter assemblycomprises a catheter body comprising at least a first lumen and a secondlumen.
 6. The intracranial access device of claim 5, wherein the firstlumen comprises an air passage.
 7. The intracranial access device ofclaim 5, wherein the second lumen comprises a drainage lumen.
 8. Theintracranial access device of claim 2, wherein the bladder is pressureconnected to an air fluid path in the catheter body.
 9. The intracranialaccess device of claim 8, wherein an air passage is held in a channelformed in a region of the catheter body.
 10. The intracranial accessdevice of claim 9, further comprising an air passage bifurcation elementpositioned at a proximal end of the catheter body, wherein the airpassage bifurcation element separates the air passage from the catheterbody.
 11. A catheter assembly, comprising; a catheter body defining achannel that extends from a proximal end to a distal end; and a bladderin communication with the catheter body; wherein the catheter bodycomprises at least a first lumen and a second lumen.
 12. The catheterassembly of claim 11, wherein the first lumen comprises an air passage.13. The catheter assembly of claim 11, wherein the second lumencomprises a drainage lumen.
 14. The catheter assembly of claim 11,wherein the bladder is held on a bladder mount positioned within abladder cage.
 15. The catheter assembly of claim 13, wherein the bladderis pressure connected to an air fluid path in the catheter body.
 16. Thecatheter assembly of claim 15, wherein an air passage is held in achannel formed in a region of the catheter body.
 17. The catheterassembly of claim 16, further comprising an air passage bifurcationelement positioned at a proximal end of the catheter body, wherein theair passage bifurcation element separates the air passage from thecatheter body.
 18. The catheter assembly of claim 14, wherein thecatheter body is made of a first material, wherein the bladder cage ismade of a second material, and wherein the second material is more rigidthan the first material.
 19. A method of assembling an intracranialaccess device, comprising: providing a bolt mountable in a skull of apatient, the bolt having a longitudinal axis; inserting an insert bodyinto the bolt, wherein the insert body has a plurality of access portsextending through the bolt; and inserting a catheter assembly within oneof the access ports of the insert body.
 20. The method of claim 19,further comprising inserting an introducer into one of the access portsof the insert body, wherein the introducer includes a probe.
 21. Themethod of claim 19, wherein the catheter assembly comprises: a catheterbody defining a channel that extends from a proximal end to a distalend; and a bladder in communication with the catheter body, wherein thecatheter body comprises at least a first lumen and a second lumen. 22.The method of claim 21, wherein the first lumen comprises an airpassage.
 23. The method of claim 21, wherein the second lumen comprisesa drainage lumen.
 24. The method of claim 23, wherein the bladder ispressure connected to an air fluid path in the catheter body.